An observational study in Breast Cancer and Adenocarcinoma of Breast, sponsored by Hellenic Cooperative Oncology Group. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by Hellenic Cooperative Oncology Group · Observational
This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.
This was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology. This study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. Patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).
12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's enrollment of 89 is below the median of 185 across 2,712 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hellenic Cooperative Oncology Group is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
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This is a transnational pooled analysis, feasibility study from two sequential studies with biological material from patients with confirmed breast cancer with high risk of recurrence. Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology.
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Exclusion Criteria:
Evaluating the feasibility profile of dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Time frame: Up to 147 days
Number of Participants with Treatment-Related Adverse Events treated with dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Time frame: Up to 147 days
No study locations are listed for this record.
Ran from Feb 2004 to primary completion in Apr 2006, 26 months.
Of 1,013 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's 26 months is below that.
Counting every sponsor, half of 1,166 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Hellenic Cooperative Oncology Group